Diabetes is a serious ailment in modern America, with recent figures from the American Diabetes Association citing more than 20 million Americans afflicted with the disease, in addition to the roughly six million who live undiagnosed and the 40 million or more Americans who could be considered pre-diabetic. In response to these ever increasing numbers, pharmaceutical companies have been under a great deal of pressure to invent new and ever better diabetes drugs to combat the illness. Rosiglitazone Maleate, also known as Avandia, is such a drug, developed by the drug maker GlaxoSmithKline and approved by the Food and Drug Administration (FDA) in May of 1999. The drug comes from the Thiazolidinedione class of anti-diabetic drugs and is approved for treatment of type 2 diabetes. Similar to other drugs in the Thiazolidinedione class, the drug Avandia functions by affecting the patient's insulin resistance, and additionally appears to have some anti-inflammatory effects. Patients should not take Avandia if they have type 1 diabetes. As with any prescription medication, patients who take Avandia have reported a number of common side effects, including: cough or cold, headache, inflammation of the sinus, back pain, and swelling or fluid retention. In addition to these more common side effects, Avandia has also been shown to cause more serious afflictions in some patients, including impairment to liver functionality, causing the FDA to warn against the drug being prescribed to patients already suffering from liver disorders. The drug can also lead to hypoglycemia, which means that patients who have been diagnosed with any variety of hypoglycemic condition should not be prescribed Avandia. While the risk of these side-effects have been long understood, a recent study published in the New England Journal of Medicine in the June 14, 2007 issue claimed that Avandia medication may increase the risk of serious heart attack in patients by 43 percent. The scale of this increased risk has caused serious concern among those type 2 diabetes patients that take Avandia to manage their diabetes on a daily basis. The release of the study's findings has also prompted the FDA to release an alert as of May 21, 2007, which states that they are aware of the possible implications the study poses and are evaluating all of the available data in order to make a determination on whether doctors should continue prescribing Avandia to patients with type 2 diabetes. At the point of its release, the FDA's warning does not necessitate an Avandia recall, as the warning states that a direct causal relationship has not been established between Avandia and increased risk of serious cardiac events possibly resulting in death, given contradictory evidence provided by two additional studies. However, the FDA does state that any patient with a heart condition or any underlying heart disease should seriously consult their doctor about the new information and the possible risk it could pose. As such, any patient taking medication such as Norvasc for Primary Pulmonary Hypertension (PPH) or any other medication related to a heart condition should seriously consider the implications of also taking Avandia, and consult with their doctor.
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